ISPE – Turkey Affiliate

Member of Our Board Banu Refik has been Elected to the Reviewer Team of ISPE!

New member of our Board Banu Refik (Conval Group) has been elected to the reviewer team of ISPE’s GAMP Good Practice Guide on Electronic Records, Data and Record Integrity. We congratulate her for this achievement based on the subject matter expertise.


ISPE Turkey Affiliate at CPhI Istanbul Exhibition!

CPhI Istanbul and its co-located events that gathered regional drug manufacturers, suppliers, solution and technology providers was held on 1 - 3 June 2016 at Istanbul Congress Center, ICC, Turkey.

The visitors were informed about the objectives, working groups and events of ISPE Turkey Affiliate via the booth that was set up at the exhibition which gathered participants from abroad, science and technology experts, government delegates and major players of the pharmaceutical sector.


General Assembly of ISPE Turkey Affiliate

The General Assembly of ISPE Turkey Affiliate was held on 4 May 2016. Following the presentation of the annual report for 2014-2015, financial statements and report of the supervisory board; the estimated budget for 2016 was conferred.

The new Board, as decided to consist of 14 people , was elected for 2 years of tenure: Fatma Taman (PharmaVision), Sabiha Buket Hekiman Bayraktar (PharmaVision), Sabine İlknur Gümüşeli Hırçın (Bayer), Havva Çınar Aşar (Bayer), Neşe Buket Aksu (İstanbul Kemerburgaz University), Ayla Deliorman (Santa Farma) and Devrim Çavuşoğlu (Pfizer) were elected as Principal Members and Fahrettin Kazak (PharmaVision), Tanju Cepheli (BASF), Zafer Öztuncer (Merck), Figen Ergin (BTS), Hülya Uslu, Yıldız Özsoy Erginer (İstanbul University), Banu Refik (Conval Group) were elected as Reserved Members.

We welcome the members of Board and wish to leave our mark on further achievements together.


Chair of ISPE Turkey Affiliate is Among the Director Candidates for Election to
ISPE International Board!

As ISPE Turkey Affiliate, we are proud to announce that our Chair Fatma Taman is among the director candidates for election to ISPE International Board which will be put to vote from June 15 to July 31, 2016.

We consider this achievement to be very significant within the scope of activities that we carry out to ensure that Turkish pharmaceutical industry is a dynamic and contributing partner of the advancing pharmaceutical world and would like to mention that notification e-mails about the official voting process will be delivered to members via ISPE Head Office.

Detailed information can be found at: http://www.ispe.org/board-election/meet-the-candidates


ISPE Europe Conference on Biotechnology
24-25 October 2016, Industriepark Höchst, Frankfurt, Germany


ISPE Europe Conference on Biotechnology will be held on 24-25 October 2016 at the Sanofi plant in Frankfurt, Germany.

The conference which promises collaborative networking with the best industry professionals through case studies, presentations, panel discussion and the opportunity to participate in a Sanofi Plant Tour will focus on revisiting the bio-manufacturing approach and perspective through the core areas of Regulatory and Quality, Knowledge Management, Process Science, Technology and Innovation.

For more information and registration: http://www.ispe.org/2016-europe-biotechnology-conference


ISPE – Turkey Affiliate
“Data Integrity Key for GMP Compliance” Workshop
26 May 2016

The first workshop of our "Data Integrity Key for GMP Compliance" working group founded in 2016 within the ISPE Turkey Affiliate, was held in May 26, 2016 at Gebze 1 facility of Sandoz.


Following opening remarks of Sandoz Gebze 1 Site Lead Şafak Öner and our Chair Fatma Taman; general titles referred at “Data Integrity” Industry Gathering that was held on March 21, 2016 at The Grand Tarabya were discussed in details; several FDA warning letters were reviewed via the interactive presentations of Figen Ergin, the leader of our working group.


Gülbengü Kuzgun Yüksel, Quality Unit Manager of Sandoz Gebze 1 gave substantial information via the presentation where she shared her experiences on data integrity based on the studies conducted on their site.

We hope to be together at our events that will be held on the continuation of the highly productive workshop where sectoral discussions were made on "Data Integrity" topic with the contributions of all participants.


ISPE Turkey Affiliate at CPhI Istanbul Exhibition!


CPhI Istanbul and its co-located events which will gather regional drug manufacturers, suppliers, solution and technology providers during 3 days will be held on 1 - 3 June 2016 at Istanbul Congress Center, ICC, Turkey.

You are invited to ISPE Turkey Affiliate booth on the B5 floor of the exhibition that will bring together science and technology experts, government delegates and major players of the pharmaceutical sector (Booth no:F39D).

For more information about the exhibition and conference: www.cphi-istanbul.com


ISPE – Turkey Affiliate
“Data Integrity Key for GMP Compliance” Workshop
26 May 2016

The first workshop of our "Data Integrity Key for GMP Compliance" working group, founded in 2016 within the ISPE Turkey Affiliate, will be held in May 26, 2016 at Gebze 1 facility of Sandoz.

General titles referred at “Data Integrity” Industry Gathering that was held on March 21, 2016 at The Grand Tarabya, will be discussed in details; several FDA warning letters will be reviewed and delegates from Sandoz will elaborate on data integrity studies conducted on the site.

We wish to be together at our workshop where Data Integrity topics will be evaluated on a sectoral basis.

Fatma Taman
Chair
ISPE Turkey Affiliate
Buket Hekiman Bayraktar
Secretary General
ISPE Turkey Affiliate
Figen Ergin
Leader of Data Integrity Working Group
ISPE Turkey Affiliate

Program (In Turkish)


“Quality & Metrics” Workshop

The first workshop of our "Quality & Metrics” working group, founded within the ISPE Turkey Affiliate in 2016 and leaded by İlknur Gümüşeli Hırçın, was held in May 4, 2016 at Topkapı facility of Bayer Turkey.


Following the General Assembly of ISPE Turkey Affiliate, the workshop was initiated with opening remarks of our Chair Fatma Taman and Board Member İlknur Gümüşeli Hırçın. Discussions around "Quality Metrics" concept, practices and challenges in this regard were covered via the detailed “Requirements and Assessment of Quality Metrics” presentation of our Board Member Havva Çınar Aşar.

We hope to be together in workshops and seminars that will be planned as sequels of our interactive workshop where sectoral discussions and assessments were made on "Quality Metrics" studies.


Good Distribution Practices for APIs, Pharmaceuticals and Biopharmaceuticals

ISPE Turkey Affiliate's Spring Seminar on “Good Distribution Practices for APIs, Pharmaceuticals and Biopharmaceuticals" was held on 15 April 2016, at Barbaros Point Hotel, Istanbul.

The seminar which brought together participants from various areas such as pharmaceutical industry, suppliers, and academy, opening remarks of our Chair Fatma Taman were followed by ISPE's Vice President for European Operations Dr. Thomas Zimmer’s presentation on the ongoing studies for ensuring the continuity of drug supply.

GDP implementations for pharmaceutical and biological products were explained by Khalid Alfhaid, International Quality Senior Manager from Amgen and real-life examples on GDPs were presented by Zafer Öztuncer, Intercontinental Quality Assurance Director from Merck Pharmaceuticals.

On the afternoon session of the seminar, Jean-Marie Higel, Head of Service Quality in Global Services at BASF presented Good Distribution Practices for APIs and Deva Holding Logistics Manager Gürcan Coşgun elaborated on the transportation requirements in the scope of GDP. The seminar was concluded with an interactive panel session where GDP topics were discussed at a wide range with the contributions of the speakers and participants.


ISPE Turkey at Cleanroom Exhibition 2016


Our Affiliate Chair Ms. Fatma Taman made a presentation with the title of "ISPE Turkey’s Perspective on Evolving Regulations and Facilities of the Future” on Thursday, April 21, 2016 at Cleanroom Technology, Maintenance and Equipment Exhibition organized on 21-23 April 2016 in ICEC – Lütfi Kırdar International Congress and Exhibition Center, İstanbul.

Following a quick overview of ISPE Turkey Affiliate’s recent accomplishments, hot topics that will soon impact the pharmaceutical industry both on a national and international level such as Industry 4.0, GMP revisions, future-proof facilities were covered and were followed with great interest by the representatives of health, medicine and chemical sectors as well as pharmaceutical and biotechnology industry experts.

The visitors were informed about the objectives, training programs, working groups and global events of ISPE Turkey Affiliate via the booth that was set up at the exhibition which gathered cleanroom specialists and managers, laboratory assistants, facilities and process managers, maintenance engineers, quality control experts and R&D managers.

For more information about the exhibition: http://www.expocleanroom.com/default.asp


ISPE Turkey Affiliate
“Quality & Metrics” Workshop
May 4, 2016
Announcement

The first workshop of our "Quality & Metrics” working group, founded in 2016 within the ISPE Turkey Affiliate, will be held in May 4, 2016 at Topkapı facility of Bayer Türk.

The workshop will begin following the General Assembly of ISPE Turkey Affiliate and will cover discussions around "Quality Metrics" concept, practices and challenges in this regard.

We wish to be together at our workshop where studies on "Quality Metrics" will be assessed and evaluated on a sectoral basis.

Pharm. Fatma Taman
Chair ISPE Turkey Affiliate
MSc. Pharm. Buket Hekiman Bayraktar
Secretary General ISPE Turkey Affiliate

 

Announcement | Program (In Turkish) | Location


ISPE Turkey Affiliate
“Good Distribution Practices for APIs,
Pharmaceuticals and Biopharmaceuticals”
15 April 2016

ISPE Turkey Affiliate's Spring Seminar on “Good Distribution Practices for APIs, Pharmaceuticals and Biopharmaceuticals" will be held on 15 April 2016, at Barbaros Point Hotel, Istanbul.

Studies for ensuring the continuity of drug supply will be presented by ISPE's Vice President for European Operations Dr. Thomas Zimmer, GDP applications for pharmaceutical and biological products will be explained by International Quality Senior Manager Khalid Alfhaid from Amgen Inc. and Intercontinental Quality Assurance Director Zafer Öztuncer from Merck Pharmaceuticals will relay information about cold chain practices for pharmaceutical and biopharmaceutical products. Following the presentation on GDP practices for APIs by Jean-Marie Higel, Head of Service Quality in Global Services at BASF; Deva Holding Logistics Manager Gürcan Coşgun will elaborate on the transportation requirements in the scope of GDP.

We look forward to your attendance to this important seminar which will cover the regulations about the storage and distribution practices for active ingredients, pharmaceuticals and biopharmaceuticals.

Pharm. Fatma Taman
Chair ISPE Turkey Affiliate
MSc. Pharm. Buket Hekiman Bayraktar
Secretary General ISPE Turkey Affiliate

Participation Fee: For Members: 900 TL, For Non-Members: 1500 TL

Deadline for registration: 8 April 2016

Seminar Program (In Turkish) | Resumes (In Turkish) | Location (In Turkish)




Career Days Event of Kemerburgaz University


Fatma Taman, Chair of ISPE Turkey Affiliate, and Buket Hekiman Bayraktar, General Secretary of ISPE Turkey Affiliate, met with future pharmacists in Career Days event of Istanbul Kemerburgaz University. During the visit on March 30th 2016, they contributed to shape future careers of pharmacist candidates by providing information about the working areas of pharmacists through the presentation titled as "Pharmacists in the Pharmaceutical Industry". Students were also guided to access current information for the pharmaceutical industry via ISPE’s knowledge resources.


ISPE 2016 Continuous Manufacturing Conference


ISPE’s Continuous Manufacturing Conference will take place on 20 – 21 April in Baltimore, Maryland – USA. The conference will focus exclusively on Continuous Manufacturing – an increasingly popular production strategy with numerous benefits, but also many challenges.
Visit the website for detailed information: http://www.ispe.org/2016-continuous-manufacturing-conference


21 March 2016 Industry Gathering


ISPE Turkey’s industry gathering around the topic of “Data Integrity” that was held at The Grand Tarabya on 21 March 2016 was initiated by an introduction of industry gathering series by the Affiliate’s Chair Fatma Taman. The meeting turned out to be a very interactive one with everyone’s contributions, following the presentations of Figen Ergin (BTS Information Services) and Timur Kabadayı (Conval Group). The group decided to take the collaborative work further at future workshop platforms.


ISPE Turkey Affiliate
Industry Gatherings: Data Integrity
21 March 2016

As of 2016, ISPE Turkey Affiliate wish to gather the representatives of our sector in the afternoon meetings that will be organized around the current issues important for our industry.

The first one of our activities in the scope of those “Industry Gatherings” will be held on March 21, 2016 and will cover the topic of "Data Integrity" which currently has an increasing effect for all of us.

Respectfully,

Pharm. Fatma Taman
Chair ISPE Turkey Affiliate
MSc. Pharm. Buket Hekiman Bayraktar
Secretary General ISPE Turkey Affiliate

Date: March 21, 2016 - Monday
Time: 17:30 - 19:30
Location: The Grand Tarabya - Rumeli & Hisar Hall

Program (In Turkish) | Location (In Turkish)




ISPE Turkey 10th Anniversary Video

Detailed information regarding the accomplishments and future goals of ISPE Turkey Affiliate can be found in the 10th anniversary video. Click here to see the video.


ISPE Turkey On the News

On the occasion of 10th Anniversary of ISPE Turkey Affiliate, our Chair Fatma Taman attended the live broadcast of Bloomberg HT news bulletin on February 24, 2016. The broadcast can be seen from here.


ISPE Turkey 10th Anniversary Celebrations

The news about our seminar "A Holistic Look at Pharmaceutical Industry on the 10th Anniversary of ISPE Turkey" and 10th Anniversary Celebration that were organized on the 3th of December, 2015 at Four Seasons Hotel, Istanbul-Sultanahmet with the attandance of delegates from the pharmaceutical industry, suppliers, academy and Turkish Medicines and Medical Devices Agency officials was published in the January-February 2016 issue of OTC News magazine.


Once again we thank all of our participants who were together with us on this important day and we would like to express our wish to carry on our tradition of conducting groundbreaking projects with which we leave our mark on the future, in the next decades with the contributions of all our stakeholders.


2016 ISPE Europe Annual Conference

The 2016 ISPE Europe Annual Conference – Integrated Technology, Quality and Compliance Strategy for Effective Operations will bring together pharmaceutical, regulatory and technology experts from around the world in Frankfurt in 7-9 March 2016.

The conference will be initiated with executive speeches around the topics of operational excellence, continuous manufacturing and new regulations for pharmaceuticals and biopharmaceuticals and will continue with paralel tracks including GMP updates, facilities of the future, data integrity, risk management and innovative approaches for technical matters.

This two-and-a-half-day, must-attend, education conference will use best practice case studies to explore current technologies, regulatory requirements and will provide delegates with techniques for the evaluation and implementation of cutting-edge technologies. The Conference is aimed at Pharma Development Experts, Quality Management, Quality Assurance, Quality Operations, Quality Control, Quality Systems, Production & Distribution Personnel, Professionals Involved in Manufacturing, Development and Technology Transfer as well as Suppliers and Regulators with interest in new solutions and experiences.

Details about the conference and registration form can be found in the following link: www.ISPE.org/2016-Europe-Annual-Conference


Thanks from ISPE Philippines

Through the Tulak Tacloban project that ISPE Philippines had supported and ISPE Turkey Affiliate had also contributed after the Typhoon Haiyan hit the Philippines in 2013, 130 schoolchildren finished primary/elementary schooling at mobile schools and these same children are now volunteers in their own community for calamity awareness.


“A Holistic Look at Pharmaceutical Industry on the 10th Anniversary of ISPE Turkey”
Seminar and 10th Anniversary Celebration / 03 December 2015


ISPE Turkey Affiliate’s seminar around the theme of “A Holistic Look at Pharmaceutical Industry on the 10th Anniversary of ISPE Turkey" and the cocktail was held on December 3, 2015 at Four Seasons Hotel Sultanahmet, İstanbul with the participation of delegates from the pharmaceutical industry, suppliers, academy and Turkish Medicines and Medical Devices Agency officials.

The presentations about Harmonization in GMPs, EU and PIC/S GMP Recent Changes were made by Dr. Vee Revithi, Turkish Medicines and Medical Devices Agency PIC/S Processes by Pharm. Gülşen Yılmaz, Management of Generation Conflicts by Dr. Buket Aksu. Fatma Taman/ Chair of ISPE Turkey Affiliate, Dr. Ünsal Hekiman/ Founder and Honorary Chairman of ISPE Turkey Affiliate, Prof. Dr. Ahmet Araman/ Past Chair of Turkey Affiliate and Dr. Theodora Kourti/ ISPE Senior Vice President for Regulatory Affairs held a speech about the ISPE’s activities with regards to the 10th Anniversary of the Affiliate.

While the Affiliate’s achievements for the past 10 years and the targets for the future were presented through the introductory video; it was also announced that grants to support education set in the name of late Board Member Zehra Gürol will be spread out with the contributions of the Affiliate’s gold sponspors.

Following the presentation of plaques to our event sponsor BTS and Founder Board Members, our 10th Anniversary was celebrated by cutting the 10th year cake all together and enjoying the cocktail reception with live classical music with the participation of all our guests.

We wish to carry on our tradition of conducting groundbreaking projects with which we leave our mark on the future, in the next decades with the contributions of all our stakeholders...

 

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10 years